Two Firms Recall Statins

Deviations from Current Good Manufacturing Practices have prompted voluntary recalls for multiple statins from RemedyRepack Inc and Preferred Pharmaceuticals Inc, according to the April 12, 2023, US Food and Drug Administration (FDA) Enforcement Report. The affected medications were distributed throughout the United States.

RemedyRepack initiated recalls for the following medications on March 20, 2023:

• atorvastatin 20-mg tablets in 30-count bottles (NDC 70518-1977-00) from lots J0659819-110922 (Exp. 11/30/23), J0649932-093022 and J0649917-093022 (Exp. 10/31/23), and B2010060-121222 (Exp. 3/31/24);
• atorvastatin 20-mg tablets in 90-count bottles (NDC 70518-1977-01) from lots B1708575-060122 (Exp. 5/31/23) and B1879236-092922 (Exp. 12/31/23);
• rosuvastatin 5-mg tablets in 30-count bottles (NDC 70518-3519-00) from lots J0668398-121422 (Exp. 12/31/23), J0661225-111522 and J0654053-101822 (Exp. 11/30/23), and J0646383-091422 (Exp. 09/30/23);
• rosuvastatin 40-mg tablets in 45-count bottles (NDC 70518-1311-01) from lots B2038806-123022, B2014185-121422, and B1925528-102522, (Exp. 7/31/25);
• rosuvastatin 40-mg tablets in 90-count bottles (NDC 70518-0484-00) from lots B2080829-012823, B1938007-110222, and B2038746-123022 (Exp. 07/31/25);
• rosuvastatin 10-mg tablets in 30-count bottles (NDC 70518-0375-03, NDC 70518-0375-01) from lots J0674788-011123 (Exp. 1/31/24), J0664118-112922 and J0664118-112922 (Exp. 12/31/23), J0653727-101722 (Exp. 10/31/23), and B2057931-011223 (Exp. 7/31/25);
• rosuvastatin 10-mg tablets in 90-count bottles (NDC 70518-0375-00) from lots B2075815-012523 (Exp. 9/30/25), B2011634-121322 (Exp. 7/31/25), B1970205-112022 (Exp. 6/30/24), B1862598-092022 (Exp. 3/31/24), and B2077226-012523 and B2070444-0123 (Exp. 7/31/25);
• simvastatin 10-mg tablets in 30-count bottles (NDC 70518-0064-01) from lots J0675206-011223 and J0669260-121922 (Exp. 1/31/24), J0656820-103122 and J0647161-091722 (Exp. 9/30/23, 11/30/23), J0621491-052722 (Exp. 6/30/23), J0638138-080822 (Exp. 8/31/23), and J0610887-041122 (Exp. 4/30/23);
• simvastatin 10-mg tablets in 90-count bottles (NDC 70518-0064-00) from lots B1887315-100422 (Exp. 2/28/24), B1829906-083122 and B1769715-071622 (Exp. 9/30/23), B1906605-101422 (Exp. 2/28/24), and B1965118-111622 (Exp. 2/28/25);
• simvastatin 40-mg tablets in 30-count bottles (NDC 70518-0060-01) from lots J0656821-103122 (Exp. 11/30/23), J0638547-080922 (Exp. 8/31/23), and J0633575-071822 (Exp. 7/31/23); and
• simvastatin 40-mg tablets in 90-count bottles (NDC 70518-0060-00) from lots B1965081-111622 (Exp. 3/31/25), B1857922-091922, B1765298-071322, B1786319-072922, and B1706842-053122 (Exp. 4/30/23), B2003311-120822 (Exp. 4/30/25), B1955679-111122 (Exp. 2/28/25), B1878942-092922 (Exp. 11/30/24), B1823203-082622 (Exp. 10/31/24), and B1706843-053122 (Exp. 5/31/23).

Preferred Pharmaceuticals Inc initiated recalls for the following medications, which were manufactured for Accord Healthcare Inc, Durham, North Carolina, on March 23, 2023:

• atorvastatin calcium tablets, 10 mg, in 90-count bottles (NDC 68788-7630-9) from lots A0523D (Exp. 5/31/24), F14220 (Exp. 7/31/23), and J0622Q (Exp. 1/31/24);
• atorvastatin calcium tablets, 20 mg, in 30-count bottles (NDC 68788-7631-3) from lots C0322B (Exp. 5/31/23), H1122G and 12322Q (Exp. 6/30/23), and J1222U (Exp. 12/31/23);
• atorvastatin calcium tablets, 20 mg, in 90-count bottles (NDC 68788-7631-9) from lots B1522B (Exp. 4/30/23), C0222H and C0322B (Exp. 5/31/23), E1022H, F13220, and H2222P (Exp. 6/30/23), I1422V and K01220 (Exp. 12/31/23), and L2722H (Exp. 3/31/24);
• pravastatin sodium tablets, 20 mg, in 90-count bottles (NDC 68788-8215-9) from lots F1021I and H3122J (Exp. 4/30/24);
• rosuvastatin tablets, 5 mg, in 30-count bottles (NDC 68788-7971-3) from lots A1723C (Exp. 8/31/25), A1922B (Exp. 6/30/24), D0622M and F2922I (Exp. 7/31/24), G3021L (Exp. 1/31/24), and H2622P and J0722C (Exp. 10/31/24);
• rosuvastatin tablets, 10 mg, in 30-count bottles (NDC 68788-7086-3) from lot F2022N (Exp. 2/29/24);
• rosuvastatin tablets, 10 mg, in 90-count bottles (NDC 68788-7086-9) from lots F0322I (Exp. 8/31/23), J1322H (Exp. 2/29/24), K0222N (Exp. 6/30/24), L2322D and L2822J (Exp. 7/31/25);
• simvastatin tablets, 10 mg, in 90-count bottles (NDC 68788-9747-9) from lots C2222P, D1522L, E3122D, and G2522J (Exp. 9/30/23), and J1222R (Exp 10/31/23);
• simvastatin tablets, 20 mg, in 30-count bottles (NDC 68788-9869-3) from lots I1521P (Exp. 1/31/24), J1322R (Exp. 9/30/24), and J1821H (Exp. 2/29/24);
• simvastatin tablets, 20 mg, in 60-count bottles (NDC 68788-9869-6) from lots F0822Q (Exp. 6/30/24), I0122J (Exp. 8/31/24), and L0821C (Exp. 5/31/24);
• simvastatin tablets, 20 mg, in 90-count bottles (NDC 68788-9869-9) from lots A0923R (Exp. 2/28/25), A1222K and B1822C (Exp. 5/31/24), C3022D and F2322V (Exp. 6/30/24), H1522H (Exp. 8/31/24), I1621O (Exp. 1/31/24), I2222G and J1822R (Exp. 9/30/24), and L1621N (Exp. 5/31/24);
• simvastatin tablets, 40 mg, in 30-count bottles (NDC 68788-9868-3) from lots A1322I (Exp. 3/31/23), and H1122C (Exp. 8/31/24);
• simvastatin tablets, 40 mg, in 60-count bottles (NDC 68788-9868-6) from lots F2922S (Exp. 8/31/23) and H0322G (Exp. 7/31/23);
• simvastatin tablets, 40 mg, in 90-count bottles (NDC 68788-9868-9) from lots B0922G (Exp. 5/31/23), F0322G (Exp. 7/25/24), H2622M (Exp. 8/31/24), J1422B and K0722G (Exp. 10/31/24), and L1922A (Exp. 2/28/25); and 
• simvastatin tablets, 80 mg, in 90-count bottles (NDC 68788-9429-9) from lots B0222S (Exp. 2/29/24), and F1121B and G2721L (Exp. 11/30/23).

The FDA has designated the recalls Class II. Drugs affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists.

Statins are available with a prescription to lower cholesterol levels in the blood.